Globally the medical device (MD) market has been growing quite rapidly over the past decade. The regulatory framework for pharmaceuticals and devices differ substantially. The regulatory authorities in different regions of the world recognize different classes of medical devices (MDs), based on their design complexity, their use characteristics, and their potential for harm, if misused. With the vast majority of MDs in developing countries being imported, the respective governments need to put in place policies & regulations to address all elements related to MDs, ranging from its development, manufacturing, registration to post-marketing obligations & disposal so that public can have access to high quality, safe & affordable products for appropriate use. This article highlights current regulations pertaining to registration of MDs in India, in light of those existing in Global Harmonization Task Force (GHTF) member countries & Association of Southeast Asian Nations (ASEAN) countries.

Introduction:
The last decade has witnessed globalization of drug development with early phase studies being increasingly placed in the developing world. Whether research related ethical principles around informed consent, adverse event (AE) reporting, post trial drug commitments and others are being observed, merits evaluation
Methods:
A specially designed survey questionnaire was served to 29 investigators in India, having prior experience of participating in drug development studies with pharmaceutical companies. The survey included questions on investigator profile, study design, informed consent process, safety reporting, patient and physician compensation, post trial drug commitments among others.
Results:
Most respondents had nearly two decades of clinical experience. Majority believed that the research they conducted was relevant to the needs of society, but wanted common research goals established between the sponsors and the community. All investigators cited their expertise, reliability, patient pool, and low costs as the principal reasons for greater placement of studies. However, very few investigators felt that all their patients in studies were "truly autonomous". Most investigators indicated confidence in the adverse event reporting ability and expressed satisfaction with their Ethics Committees. A third of investigators accepted some form of conflict of interest between their role as a physician and researcher. Opinion was divided regarding satisfaction with the post trial drug commitments of the sponsor companies.
Conclusion:
The survey revealed a good understanding of the ethical issues around conduct of clinical research in a developing country. The sooner ethical institutions and practices are fortified, the better it is for communities, patients, investigators and pharmaceutical sponsors.

Readability and comprehensibility of informed consent forms for clinical trials

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Anvita PandiyaPMID:21814628

The signed informed consent form provides documentary evidence that the patient has given informed consent to participate in a clinical trial and that the patient has been given the requisite information. However, this document must not only provide the necessary information, it must also be provided in a way that can be understood by the patient. Non conclusive information suggests that research participants frequently may not understand the information presented during the informed consent procedure. Comprehension requires that the patient be able to understand the information presented and have the time and opportunity to read, evaluate and consider the information presented.
A shortened Informed Consent Form, with information that a reasonable person would want to understand along with specific information that the person wants in particular would be a good option to improve understanding or comprehensibility. Additional informational meetings with a qualified person like a counselor could help in comprehension. Questionnaires designed to test comprehension of patient, peer review, patient writing the salient features could help evaluate the comprehensibility of the Informed Consent Form.

Clinical trial participants should not be influenced by undue inducement. Clinical trial investigators should be guided by ethical principles, and patient protection should be a top priority. This does not seem to be the case in India.

With increasing health care cost, focus needs to be given towards value-for-money, especially in the context of innovative drugs. A multi-disciplinary approach towards drug development is important in order to demonstrate the value of innovation to physicians and patients. Input into the drug development process at various stages of clinical trials must incorporate patient-focused endpoints and analyses. Demonstrating value of drugs will help ensure that innovative therapies should be seen as health care investment and not expense.

Conducting feasibilities in clinical trials: An investment to ensure a good study

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Viraj RajadhyakshaPMID:21814631

Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

Core perspectives on the traditional approach to CDM are rapidly changing and EDC and new eclincal initiatives are redefining the face of data management. Associated with EDC are not only the higher efficiencies, resulting in lower study costs, but its applications in key areas such as adaptive trials and clinical event adjudication; however the cost and effort involved in deployment and integration remain a deterrent. The role of the data manager may change to that of a data broker who manages the exchange of data from multiple sources, and semantic interoperability, data standards and data privacy will prove to be the defining factors. Simulation modeling, pharmacogenomics, personalized medicine and EHRs will no longer exist as silos and seamless data flows will be the drivers of healthcare solutions.